BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL SHELL WITH CLUSTER HOLES

    MDR report key: 3261265 · Received July 31, 2013

    Report

    Report Number
    1822565-2013-01166
    Event Type
    Injury
    Date Received
    July 31, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER X-RAYS NOR SURGICAL NOTES HAVE BEEN PROVIDED TO ASSESS COMPONENT FIT, COMPATIBILITY, AND POSITION PER THE SURGICAL TECHNIQUE. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS HAD PAIN SINCE HER TOTAL HIP REPLACEMENT IN (B)(6) 2010. RECENTLY THE PAIN HAS BECOME MUCH WORSE AS WELL AS HER LEG HAS BEEN SWELLING UNDER THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358090 TRABECULAR METAL SHELL WITH CLUSTER HOLES KWZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRILOGY LONGEVITY LINER: CATALOG# 00630505036,| LOT# UNK